A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
Stopped early · Phase 2
Conditions studied: Neurogenic Detrusor Overactivity
In brief
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity. The results will support a benefit-risk based dosage recommendation for phase IIIa clinical trials.
Key facts
- Study ID
- NCT00712322
- Run by
- Warner Chilcott
- People needed
- 35
- Starts
- 2008-10-07
- Expected to finish
- 2013-05-23
- Last updated by the study team
- 2022-06-09
Who can join
Age: 2 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female participants ages 2-15 years
- Documented detrusor overactivity associated with a known neurological condition such as meningomyelocele or spinal cord injury, and confirmed by urodynamics at baseline
- Using clean intermittent catheterization (CIC) on a regular basis
- Participating in a bowel program on a regular basis
- Able to swallow the study medication in accordance to the protocol
- Participants and/or parent/guardian able to complete the bladder diary and follow the study procedures
You may not qualify if…
- Treatment with drugs known to significantly affect the urinary bladder and urinary bladder outlet function
- Fecal impaction. Participants may be included, once this condition has resolved
- Clinically significant anatomical abnormalities or acquired disorders of the urinary tract
- Previous reconstructive surgery (augmentation etc.) of the bladder or bladder outlet
- Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
- Diabetes insipidus
- Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any time during the study
- Concomitant diseases, in which the use of darifenacin is contraindicated
- History of hypersensitivity to darifenacin or to drugs with similar chemical structures
- Participants with any physical and cognitive impairment or any other condition which in the opinion of the investigator makes the participants unsuitable for inclusion
- Female adolescent of child-bearing potential, unless using an acceptable method of contraception
- Pregnant or nursing (lactating) female adolescents Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- University of California at San Diego — San Diego, California, United States
- Children's Hospital, Karp 8210 — Boston, Massachusetts, United States
- Children's Hospital of Michigan — Detroit, Michigan, United States
- Washington University Pediatric Urology — St Louis, Missouri, United States
- Pediatric Urology Associates, PC — Lake Success, New York, United States
- Pediatric Urology Associates PC — Tarrytown, New York, United States
- Pediatric & Adolescent Urology, Inc Akron Children's Hospital — Akron, Ohio, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Fundacion Hospital Infantil, Universitario De San Jose — Bogotá, Colombia
- Fundación Valle de Lili — Cali, Colombia
- Hospital Pablo Tobon Uribe — Medellín, Colombia
Full record on ClinicalTrials.gov
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